HiMedia is a leading Indian biotechnology company specializing in the manufacturing and distribution of high-quality laboratory chemicals and media. Established in 1973, HiMedia has grown to become a global player in the industry, serving researchers and scientists worldwide.
WE ARE HIRING
For Life is Precious
Manager- Regulatory Affairs (Microbiology)
•To ensure that company’s products comply with medical device regulations of different regions where they intend to be marketed.
•Well versed with Medical Devices Rules followed in India & overseas
•To involve in registrations of medical devices in CDSCO and other international regulatory agencies
•Collaborate with cross-functional teams (e.g., R&D, Quality, Manufacturing, etc). for inputs in dossier preparation.
•Dossier preparations such as Device master file for CDSCO, Technical files preparation for Europe submissions.
•Preparation of post market surveillance reports, Incident reports to regulatory agencies.
•Additional knowledge of ANVISA, TGA, US FDA, SFDA REACH, MEDSAP can be an added advantage.
•Should be well versed with online application processes of CDSCO and NSWS- for obtaining Manufacturing license, Test license, Import license, Free Sale certification, Non-conviction certificate, Post approval process, License renewal etc.
•Capacity to manage data for accurate presentation of documents to authorities as and when required.
•Participate in CDSCO and other regulatory audits and FDA inspections while abiding to the rules and regulations set by government
•Respond to queries from regulatory authorities.
•Train personnel on regulatory requirements.
Qualification:
•Ph.D./Master’s degree in microbiology/biotechnology + diploma or equivalent in regulatory or related field required.
•Five to six years (for Ph.D.), 9-10 years (for MSc.) of related experience required.
Job location:
Thane, Wagle Estate
Share your CV:
[email protected]
visit us at:
www.himedialabs.com
